Actively Recruiting
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Led by Takeda · Updated on 2025-12-29
183
Participants Needed
16
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation. This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461) and TAK-279-UC-2001 (NCT06254950). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study. The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD. The participants will be treated with TAK-279 for up to 2 years (108 weeks). During the study, participants will visit their study clinic 11 times.
CONDITIONS
Official Title
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to understand and comply with study procedures, including digital tools
- Provided signed informed consent before starting trial procedures
- Completed 52 weeks in the parent phase 2 Crohn's Disease or Ulcerative Colitis trials with valid electronic diary data
- Showed clinical or symptomatic response to TAK-279 treatment by Week 52 in the parent trial
- Meet contraception recommendations during the study
You will not qualify if you...
- Considered unsuitable for the extension study due to compliance or medication adherence concerns
- History of malignancy or dysplasia during the parent trial or at extension study start
- Meet specific laboratory exclusion criteria defined by the study protocol
- Taking oral corticosteroids for Crohn's Disease or Ulcerative Colitis at or after Week 48 of the parent trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
2
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
Actively Recruiting
3
Chongqing General Hospital
Chongqing, Chongqing Municipality, China, 400013
Actively Recruiting
4
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangdong, China, 510080
Actively Recruiting
5
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
6
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 2000127
Actively Recruiting
7
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, Czechia, 500 12
Actively Recruiting
8
Pannonia Maganorvosi Centrum
Budapest, Hungary, 1136
Actively Recruiting
9
St. Antonius Ziekenhuis
Tilburg, North Brabant, Netherlands, 5022GC
Actively Recruiting
10
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
11
Centrum Medyczne MedykSp. z o.o. Sp. K.
Lublin, Poland, 35-326
Actively Recruiting
12
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland, 71-434
Actively Recruiting
13
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 04-730
Actively Recruiting
14
Endomed
Košice, Slovakia, 4013
Actively Recruiting
15
Inje University Haeundae Paik Hospital
Haeundae, Busan Gwangyeogsi, South Korea, 48108
Actively Recruiting
16
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea, 220-701
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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